๐ Indications & Clinical Dosage
*Hypercalcaemia of malignancy:*
BY IV INF: Adult: 15-60 mg, to be given via cannula in a relatively large vein as a single INF or in divided doses over 2-4 days, dose adjusted according to serum calcium concentration; max. 90 mg per course.
*Osteolytic lesions and bone pain in bone metastases associated with breast cancer or multiple myeloma:*
BY IV INF: Adult: 90 mg every 4 weeks, to be administered via cannula in a relatively large vein, dose may alternatively be administered every 3 weeks, to coincide with chemotherapy in breast cancer.
*Pagets disease of bone:*
BY IV INF: Adult: 30 mg every week for a 6 week course (total dose180 mg), alternatively initially 30 mg once weekly for 1 week, then increased to 60 mg every 2 weeks (max. per dose 60 mg) for a 6 week course (total dose 210 mg), to be administered via cannula in a relatively large vein, course may be repeated every 6 months; max. 360 mg per course
Adults: Capsule: 200 mg daily.
Children: Not recommended.
๐ Mode of Administration
Drug must be properly diluted before administration and slowly infused IV (over at least 2 hours).
RECONSTITUTION: Powder for injection: Reconstitute by adding 10 ml of sterile water for injection to each vial of lyophilized pamidronate disodium powder, the resulting solution will be 30 mg/ ml or 90 mg/ ml. Pamidronate may be further diluted in 250-1000 ml of 0.45% or 0.9% sodium chloride or 5% dextrose.
โ ๏ธ Precautions & Warnings
Renal impairment, cardiac disease, previous thyroid surgery, atypical femoral fractures. Ensure adequate hydration, possibility of precipitating convulsions. Monitor serum electrolytes, calcium and phosphate during prolonged use, monitor renal function.
๐ Drug Interactions
Infusions of solutions containing calcium, hy-pocalcaemic therapy, other diphosphonates, plicamycin.
โ ๏ธ Adverse Reactions / Side Effects
Abdominal pain, anaemia, anorexia, arthralgia, bone pain, constipation, diarrhoea, drowsiness, fever, headache, hypertension, hypomagnesaemia, hypophosphataemia, influenza- like symptoms, insomnia, myalgia, nausea, paraesthesia, rash, symptomatic hypocalcaemia, tetany, thrombocytopenia, vomiting, mild transient pyrexia, transient lymphocytopenia, infusion site reactions, Rarely, leucopenia, anaemia, other biochemical disturbances.
๐คฐ Pregnancy & Lactation Safety
Pregnancy Risk:
Positive evidence of risk, use only when no safer alternative exists for a serious problem.
Lactation / Breastfeeding:
: Caution advised
๐งช Compatibility & Storage Stability
Stability & Storage: Powder for injection: Store below 30C. The recon-stituted solution made by adding 10 ml of SWFI to each vial of lyophilized powder (3o mg/10 ml or 90 mg/10 ml) will be stable for 24 hours stored under refrigeration at 2C-8T. Solution for injection: Store at 20C-25C.
๐ Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.